FDA.reportPublic FDA data

HAND PENDANT, ZENTRUM

Primary DI
00842430106019
Brand
HAND PENDANT, ZENTRUM
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
8001
Catalog number
8001
Published
2018-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDCTable, Operating-Room, Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDCTable, Operating-Room, ElectricalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430106019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430106019008424301060198424301060190842430106019

GMDN Terms#

Term, Definition table
TermDefinition
Operating room equipment remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an operating table (e.g., orthopaedic operating table, ophthalmic operating table), lights, and/or cameras in the operating room (OR) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10842430116749PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
10842430116756PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
00842430109188PRONECONNECT PROTECTIVE HELMETPC501FHPC501FH2025-08-29
00842430109195PRONECONNECT ADJUSTABLE HELMETPC502AHPC502AH2025-08-29
00842430109201PRONECONNECT COMBO PACK 4L, 3M, 3SPC-COMBOPC-COMBO2025-08-29
00842430109218PRONECONNECT LOW PROFILE MIRRORPC520MPC520M2025-08-29
00842430109225PRONECONNECT ADJUSTABLE MIRRORPC590MPC590M2025-08-29
00842430109232PRONECONNECT MIRROR WITH POST HOLESPC580MPC580M2025-08-29
00842430109249PRONECONNECT TRIOS MIRROR PLATFORMPC700MPC700M2025-08-29
00842430109256PRONECONNECT CUSHION INSERT, SINGLE, SPC507EAPC507CS2025-08-29
00842430109263PRONECONNECT CUSHION INSERT, SINGLE, MPC505EAPC505CS2025-08-29
00842430109270PRONECONNECT CUSHION INSERT, SINGLE, LPC503EAPC503CS2025-08-29
00842430109287PRONECONNECT ADJUSTABLE HELMET & MIRRORPC510HMPC510HM2025-08-29
00842430109140ADANTE KNEE PROCEDURE KIT, LEFT6895K-L6895K-L2025-07-28
00842430109157ADANTE KNEE PROCEDURE KIT, RIGHT6895K-R6895K-R2025-07-28
00842430109164ADANTE DAA HIP PROCEDURE KIT, LEFT6895AH-L6895AH-L2025-07-28
00842430109171ADANTE DAA HIP PROCEDURE KIT, RIGHT6895AH-R6895AH-R2025-07-28
00842430116728TRAPEZE ARM ASSEMBLY, PATIENT HELPER3423-053423-052025-07-28
00842430116261KIT, HANA SSXT MAQUET 1140 VERSION687668762023-01-17
10842430111539PKIT, INDIV W/SHEARGARD, SST-3000 (1)5819-158192022-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00615521070069ALLENHILL-ROM, INC.GDC2026-02-27
00724995244972NASTERIS CORPORATIONGDC2026-02-13
06975678805018PAXShanghai PAX Medical Instrument Co., Ltd.GDC2026-02-13
04260647941494SC 5010 ESAKRUS GmbH & Co. KGGDC2025-11-28
04260647941500SC 5010 HSAKRUS GmbH & Co. KGGDC2025-11-28
04260647941579SB 5010 ESAKRUS GmbH & Co. KGGDC2025-11-28
04260647941586SB 5010 HSAKRUS GmbH & Co. KGGDC2025-11-28
04260647946321Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946338Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946345Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946376Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946383Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946390Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946406Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946420Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946437Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946444Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04260647946451Surgeon chair ak 480AKRUS GmbH & Co. KGGDC2025-11-28
04946329173932Operating Table VACB-3006BMIZUHO CORPORATIONGDC2025-09-05
04946329308259Operating Table VACB-3006B Type150SMIZUHO CORPORATIONGDC2025-09-05
04946329385847Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329385854Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329385861Narrow head sectionMIZUHO CORPORATIONGDC2025-09-05
04946329404555Operating Table MST-7300BXMIZUHO CORPORATIONGDC2025-09-05
07640143930043Intermediate plate Schaerer Medical AGGDC2025-07-23
07640143930050Intermediate plateSchaerer Medical AGGDC2025-07-23
07640143930166Side rail adapterSchaerer Medical AGGDC2025-07-23
07640143930180Side rail adapterSchaerer Medical AGGDC2025-07-23
07640143930807Side rail (1 pcs.)Schaerer Medical AGGDC2025-07-23
07640143930852Leg plates 2-part Schaerer Medical AGGDC2025-07-23